NDA 013295

LIEBEL-FLARSHEIM

FDA Drug Application

Application #013295

Documents

• Letter: 2003-06-22
• Letter: 2014-07-10
• Letter: 2015-07-10
• Label: 2015-07-09
• Label: 2017-04-06
• Letter: 2017-04-12
• Letter: 2022-02-22
• Label: 2022-02-23

Application Sponsors

NDA 013295

LIEBEL-FLARSHEIM

Marketing Status

• Prescription: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	60%	1	CONRAY	IOTHALAMATE MEGLUMINE
002	INJECTABLE;INJECTION	43%	1	CONRAY 43	IOTHALAMATE MEGLUMINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1962-08-16	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1975-08-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1975-07-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1976-01-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1976-01-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1976-05-06	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1976-05-05
LABELING; Labeling	SUPPL	25	AP	1978-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1978-10-17	PRIORITY
EFFICACY; Efficacy	SUPPL	27	AP	1978-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1978-10-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1978-08-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1978-10-20	PRIORITY
EFFICACY; Efficacy	SUPPL	31	AP	1982-10-20
LABELING; Labeling	SUPPL	32	AP	1979-12-07
EFFICACY; Efficacy	SUPPL	33	AP	1983-01-26
LABELING; Labeling	SUPPL	34	AP	1983-02-25
LABELING; Labeling	SUPPL	36	AP	1983-01-26
LABELING; Labeling	SUPPL	38	AP	1982-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1982-10-20	PRIORITY
LABELING; Labeling	SUPPL	40	AP	1984-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1984-06-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1984-12-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1989-10-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1989-06-28	PRIORITY
LABELING; Labeling	SUPPL	45	AP	1984-09-12
LABELING; Labeling	SUPPL	46	AP	1984-10-25
EFFICACY; Efficacy	SUPPL	47	AP	1985-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1985-04-08	PRIORITY
LABELING; Labeling	SUPPL	49	AP	1986-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1989-10-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1988-08-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1989-12-01	PRIORITY
LABELING; Labeling	SUPPL	53	AP	1989-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1990-03-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1992-12-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1992-08-28	PRIORITY
LABELING; Labeling	SUPPL	57	AP	1995-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1999-10-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	2001-02-26	PRIORITY
LABELING; Labeling	SUPPL	60	AP	2003-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	2013-05-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	2013-05-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	2013-07-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	2013-12-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	2014-02-25	PRIORITY
LABELING; Labeling	SUPPL	66	AP	2014-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	2015-02-03	PRIORITY
LABELING; Labeling	SUPPL	68	AP	2015-07-06	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	2016-06-22	PRIORITY
LABELING; Labeling	SUPPL	70	AP	2017-04-05	STANDARD
LABELING; Labeling	SUPPL	72	AP	2022-02-18	STANDARD

Submissions Property Types

SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	48	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	15
SUPPL	67	Null	0
SUPPL	68	Null	6
SUPPL	69	Null	0
SUPPL	70	Null	15
SUPPL	72	Null	15

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13295
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)